Postpartum HemorrhagePhase 1NCT06364098
Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections
A Phase 1 study testing Misoprostol in people with Postpartum Hemorrhage, run by Cairo University at 1 site in Egypt.
Trial summary
Study design: A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University. Population of study: 192 pregnant women at the age range from 20 to 35 years, with BMI < 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age >39… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Misoprostol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20-35 years.
- BMI < 30kg/m2.
- Singleton pregnancy.
- Full term pregnancies (recruiting from 37 weeks of gestation).
- Elective cesarean section (previous one or two cesarean section).
Who cannot join
- Active labour before 39 weeks.
- Uterine over distension as due to multiple pregnancies or polyhydramnios.
- Multipara [parity ≥3].
- Pregnancy with obstetric haemorrhage such as placenta Previa, placental abruption or vasa Previa.
- Moderate to severe anemia with HB <9mg/dL.
- Pregnancy with coagulopathy, thrombocytopenia or blood dyscrasias.
Show all 9Show fewer
- Women with uterine fibroids.
- Medically complicated pregnancy (pregnancy induced hypertension, cardiovascular, DM, hepatic, or renal disorders).
- Women with any contraindication for the use of misoprostol or oxytocin as a history of prostaglandin allergy and current medication which could cause severe drug interaction to prostaglandins such as topical dinoprostone, magnesium-containing antacids or quinapril.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections: A Randomized Controlled Trial
Study design:
A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University.
Read more
Population of study:
192 pregnant women at the age range from 20 to 35 years, with BMI < 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age >39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level <9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study.
Read the detailed description
After receiving the research approval of the Scientific and Ethical Committee of the Obstetrics and Gynecology department, Cairo University, the study purpose was clarified simply and in a lay Arabic speech to all women before registering in the study, and the enrolled women signed informed consent form. Pregnant women who met all the inclusion criteria were evaluated for enrollment. Prior to the study, randomization schedules created by computer program were designed and settled in serially numbered secured opaque envelopes. Simple randomization was applied at one to one ratio within both groups. The recruited women - after giving consent for participation- opened the sealed randomization envelopes for revealing the allocation.
All participants were subjected to Comprehensive history taking including obstetric, medical, and surgical history.
General examination excluding the presence of any abnormalities. Systematic obstetrical examinations. A transabdominal ultrasound to confirm the diagnosis and evaluation of fetal condition.
A blood sample collected for complete blood counting, coagulation studies, liver and kidney function tests.
All women were subjected to elective lower segment cesarean section by the same team under spinal anesthesia and antibiotic prophylaxis according hospital protocol.
Women were divided into two equal groups:
Group A: 96 women receiving 400 mcg intrauterine misoprostol + IV oxytocin. Group B: 96 women receiving 400 mcg sublingual misoprostol + IV oxytocin. Both groups were subjected to the same preparation. All cesarean deliveries were performed by a senior obstetrics and gynecology resident and the elective sections were performed at 39th weeks gestation adopting the following operative steps: transverse skin incision (Pfannenstiel), smiley incision at the lower uterine segment, immediate clamping of the cord within 30 seconds, placental extraction after its spontaneous separation, two layers closure of the uterine incision, and abdominal closure anatomically in layers. All surgical steps were done with adequate hemostasis. Furthermore, the investigators excluded sections exceeding 90 minutes from skin incision to skin closure.
After fetal head extraction, participants in both groups were given 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) as intravenous bolus and continued on infusion of 10 IU oxytocin in 500 mL of Ringer lactate at a rate of 125 mL/hour.
- For all women in group A: the surgeon placed two intrauterine misoprostol tablets (Misotac® 200microgram, Sigma Ph., Egypt) at the fundus after placental delivery and swabbing the cavity followed by suturing the first layer of the uterus, while women in group B were given two sublingual misoprostol tablets (Misotac® 200 microgram, Sigma Ph., Egypt) after placental delivery.
- The amount of blood loss was determined through the standardized visual estimation method and rectified by measuring the amount of intraoperative blood loss and 6 hours after surgery. The estimated total blood loss during cesarean section was measured after adding the volume of blood in the suction bottle to the soaked surgical towels (weighting method) then added to the amount of blood lost after section calculated by using blood collection drape. Moreover, hemoglobin (HB) level and hematocrit value were repeated 24 hours postpartum. The patient vitals were observed and recorded intraoperatively and postoperatively.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
400 microgram of misoprostol given either sublingually or intrauterine during CS after placental removal together with IV oxytocin infusion
| Study group | Role | What they receive |
|---|---|---|
| intrauterine misoprostol group (Group A) | Experimental | 96 women receiving 400 mcg intrauterine misoprostol + IV oxytocin. Receives: Drug: Misoprostol |
| sublingual misoprostol group (Group B) | Active comparator | : 96 women receiving 400 mcg sublingual misoprostol + IV oxytocin. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of blood loss
determined through the standardized visual estimation method and rectified by measuring the amount of intraoperative blood loss and 6 hours after surgery
Measured: 6 hours
Secondary outcomes (2)
Changes in hematocrit values in both groups after delivery
Hematocrit values measured before section and 24 hours after section
Measured: 24 hours
Changes in Hemoglobin level measured by gm/dl in both groups after delivery
Hemoglobin level in gm/dl measured before section and 24 hours after section
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jan 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Atef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364098
- Sponsor's protocol ID
- prevention of PPH
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gallos I, Williams H, Price M, Pickering K, Merriel A, Tobias A, Lissauer D, Gee H, Tuncalp O, Gyte G, Moorthy V, Roberts T, Deeks J, Hofmeyr J, Gulmezoglu M, Coomarasamy A. Uterotonic drugs to prevent postpartum haemorrhage: a network meta-analysis. Health Technol Assess. 2019 Feb;23(9):1-356. doi: 10.3310/hta23090.
PubMed 30821683Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.
PubMed 29693726Escobar MF, Nassar AH, Theron G, Barnea ER, Nicholson W, Ramasauskaite D, Lloyd I, Chandraharan E, Miller S, Burke T, Ossanan G, Andres Carvajal J, Ramos I, Hincapie MA, Loaiza S, Nasner D; FIGO Safe Motherhood and Newborn Health Committee. FIGO recommendations on the management of postpartum hemorrhage 2022. Int J Gynaecol Obstet. 2022 Mar;157 Suppl 1(Suppl 1):3-50. doi: 10.1002/ijgo.14116. No abstract available.
PubMed 35297039Awoleke JO, Adeyanju BT, Adeniyi A, Aduloju OP, Olofinbiyi BA. Randomised Controlled Trial of Sublingual and Rectal Misoprostol in the Prevention of Primary Postpartum Haemorrhage in a Resource-Limited Community. J Obstet Gynaecol India. 2020 Dec;70(6):462-470. doi: 10.1007/s13224-020-01338-0. Epub 2020 Jun 29.
PubMed 33417650Bagheri FZ, Azadehrah M, Shabankhani B, Nasiri Formi E, Akbari H. Rectal vs. sublingual misoprostol in cesarean section: Three-arm, randomized clinical trial. Caspian J Intern Med. 2022 Winter;13(1):84-89. doi: 10.22088/cjim.13.1.84.
PubMed 35178212Atef A, Shehata HSEAM, Bassiouny YA, Al-Inany HG. Comparative study between the roles of intrauterine misoprostol versus the sublingual route for prevention of postpartum blood loss in elective cesarean sections: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Oct 29;24(1):710. doi: 10.1186/s12884-024-06889-y.
PubMed 39472831
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06364098
- Acronym / sponsor ID
- prevention of PPH
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study design:
A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University.
Population of study:
192 pregnant women at the age range from 20 to 35 years, with BMI < 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age >39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level <9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study.
Detailed description
After receiving the research approval of the Scientific and Ethical Committee of the Obstetrics and Gynecology department, Cairo University, the study purpose was clarified simply and in a lay Arabic speech to all women before registering in the study, and the enrolled women signed informed consent form. Pregnant women who met all the inclusion criteria were evaluated for enrollment. Prior to the study, randomization schedules created by computer program were designed and settled in serially numbered secured opaque envelopes. Simple randomization was applied at one to one ratio within both groups. The recruited women - after giving consent for participation- opened the sealed randomization envelopes for revealing the allocation.
All participants were subjected to Comprehensive history taking including obstetric, medical, and surgical history.
General examination excluding the presence of any abnormalities. Systematic obstetrical examinations. A transabdominal ultrasound to confirm the diagnosis and evaluation of fetal condition.
A blood sample collected for complete blood counting, coagulation studies, liver and kidney function tests.
All women were subjected to elective lower segment cesarean section by the same team under spinal anesthesia and antibiotic prophylaxis according hospital protocol.
Women were divided into two equal groups:
Group A: 96 women receiving 400 mcg intrauterine misoprostol + IV oxytocin. Group B: 96 women receiving 400 mcg sublingual misoprostol + IV oxytocin. Both groups were subjected to the same preparation. All cesarean deliveries were performed by a senior obstetrics and gynecology resident and the elective sections were performed at 39th weeks gestation adopting the following operative steps: transverse skin incision (Pfannenstiel), smiley incision at the lower uterine segment, immediate clamping of the cord within 30 seconds, placental extraction after its spontaneous separation, two layers closure of the uterine incision, and abdominal closure anatomically in layers. All surgical steps were done with adequate hemostasis. Furthermore, the investigators excluded sections exceeding 90 minutes from skin incision to skin closure.
After fetal head extraction, participants in both groups were given 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) as intravenous bolus and continued on infusion of 10 IU oxytocin in 500 mL of Ringer lactate at a rate of 125 mL/hour.
- For all women in group A: the surgeon placed two intrauterine misoprostol tablets (Misotac® 200microgram, Sigma Ph., Egypt) at the fundus after placental delivery and swabbing the cavity followed by suturing the first layer of the uterus, while women in group B were given two sublingual misoprostol tablets (Misotac® 200 microgram, Sigma Ph., Egypt) after placental delivery.
- The amount of blood loss was determined through the standardized visual estimation method and rectified by measuring the amount of intraoperative blood loss and 6 hours after surgery. The estimated total blood loss during cesarean section was measured after adding the volume of blood in the suction bottle to the soaked surgical towels (weighting method) then added to the amount of blood lost after section calculated by using blood collection drape. Moreover, hemoglobin (HB) level and hematocrit value were repeated 24 hours postpartum. The patient vitals were observed and recorded intraoperatively and postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrauterine misoprostol group (Group A) | Experimental | Drug: Misoprostol96 women receiving 400 mcg intrauterine misoprostol + IV oxytocin. |
| sublingual misoprostol group (Group B) | Active comparator | Drug: Misoprostol: 96 women receiving 400 mcg sublingual misoprostol + IV oxytocin. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 20-35 years.
- BMI < 30kg/m2.
- Singleton pregnancy.
- Full term pregnancies (recruiting from 37 weeks of gestation).
- Elective cesarean section (previous one or two cesarean section).
Key exclusion criteria (9 listed)
- Active labour before 39 weeks.
- Uterine over distension as due to multiple pregnancies or polyhydramnios.
- Multipara [parity ≥3].
- Pregnancy with obstetric haemorrhage such as placenta Previa, placental abruption or vasa Previa.
- Moderate to severe anemia with HB <9mg/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol400 microgram of misoprostol given either sublingually or intrauterine during CS after placental removal together with IV oxytocin infusion | Drug | intrauterine misoprostol group (Group A), sublingual misoprostol group (Group B) |
Primary outcome
The amount of blood loss
Time frame: 6 hours
determined through the standardized visual estimation method and rectified by measuring the amount of intraoperative blood loss and 6 hours after surgery
2 secondary outcomes
Changes in hematocrit values in both groups after delivery
Time frame: 24 hours
Changes in Hemoglobin level measured by gm/dl in both groups after delivery
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Background: PubMed 30821683Gallos I, Williams H, Price M, Pickering K, Merriel A, Tobias A, Lissauer D, Gee H, Tuncalp O, Gyte G, Moorthy V, Roberts T, Deeks J, Hofmeyr J, Gulmezoglu M, Coomarasamy A. Uterotonic drugs to prevent postpartum haemorrhage: a network meta-analysis. Health Technol Assess. 2019 Feb;23(9):1-356. doi: 10.3310/hta23090.
- Background: PubMed 29693726Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.
- Background: PubMed 35297039Escobar MF, Nassar AH, Theron G, Barnea ER, Nicholson W, Ramasauskaite D, Lloyd I, Chandraharan E, Miller S, Burke T, Ossanan G, Andres Carvajal J, Ramos I, Hincapie MA, Loaiza S, Nasner D; FIGO Safe Motherhood and Newborn Health Committee. FIGO recommendations on the management of postpartum hemorrhage 2022. Int J Gynaecol Obstet. 2022 Mar;157 Suppl 1(Suppl 1):3-50. doi: 10.1002/ijgo.14116. No abstract available.
- Background: PubMed 33417650Awoleke JO, Adeyanju BT, Adeniyi A, Aduloju OP, Olofinbiyi BA. Randomised Controlled Trial of Sublingual and Rectal Misoprostol in the Prevention of Primary Postpartum Haemorrhage in a Resource-Limited Community. J Obstet Gynaecol India. 2020 Dec;70(6):462-470. doi: 10.1007/s13224-020-01338-0. Epub 2020 Jun 29.
- Background: PubMed 35178212Bagheri FZ, Azadehrah M, Shabankhani B, Nasiri Formi E, Akbari H. Rectal vs. sublingual misoprostol in cesarean section: Three-arm, randomized clinical trial. Caspian J Intern Med. 2022 Winter;13(1):84-89. doi: 10.22088/cjim.13.1.84.
- Derived from this study: PubMed 39472831Atef A, Shehata HSEAM, Bassiouny YA, Al-Inany HG. Comparative study between the roles of intrauterine misoprostol versus the sublingual route for prevention of postpartum blood loss in elective cesarean sections: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Oct 29;24(1):710. doi: 10.1186/s12884-024-06889-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Misoprostol in people with Postpartum Hemorrhage, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of blood loss (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06364098, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.